Assembly and method for left atrial appendage occlusion

ABSTRACT

An assembly and method for performing the occlusion of the left atrial appendage including a delivery instrument being positioned in communicating relation with the interior of the left atrial appendage and disposing a distal end portion of the delivery instrument in covering relation to the entrance thereof. Occlusion material is movably connected to the delivery instrument and includes at least one elongated single strand of flexible material. A length of the single strand is progressively fed through the delivery instrument into the interior of the left atrial appendage and the flexibility thereof is sufficient to progressively form an arbitrarily intermingled array of occlusion material therein. The dimension and configuration of the formed arbitrarily intermingled array is sufficient to fill a predetermined portion of the interior of the left atrial appendage and thereby conform to the configuration thereof.

CLAIM OF PRIORITY

The present application is a continuation-in-part application ofpreviously filed, now pending application having Ser. No. 13/714,989,filed on Dec. 14, 2012.

BACKGROUND OF THE INVENTION

Field of the Invention

This invention is directed to an assembly and method for performing theocclusion of a left atrial appendage of the heart and includes adelivery instrument having occlusion material movably connected theretoand disposable outwardly therefrom. The occlusion material comprises atleast one elongated single strand of flexible material having sufficientflexibility to progressively form an arbitrarily intermingled array ofocclusion material within the interior of the left atrial appendage asit is progressively fed therein in a manner which substantially fillsand conforms to the interior configuration thereof.

Description of the Related Art

The left atrial appendage (LAA) is a muscular pouch connected to theleft atrium of the heart. It functions as a reservoir for the leftatrium but may present serious consequences or problems to theindividual when blood pools therein. Such pooling of blood in theappendage may arise spontaneously or due to atrial fibrillation and mayresult in the formation of blood clots. Moreover, the exiting of theformed blood clot from the interior of the left atrial appendage intothe blood stream can cause serious problems when they embolize in thearterial system. Importantly, embolization of these clots is a frequentcause of stroke. Accordingly, it is extremely important to prevent suchblood clot formation and/or the migration of a formed clot from theinterior of the left atrial appendage in order to reduce the possibilityof stroke occurrence, especially in patients with atrial fibrillation.

One common method of reducing the risk of clot formation is thetreatment of an individual with anticoagulants such as but not limitedto Warfarin. While this method has been generally effective in reducingthe occurrence of strokes in a treated patient, such strokes may stilloccur if there is a necessary or inadvertent lapse of treatment. Anadditional disadvantage or problem in the anticoagulant treatment is thefact that it is contraindicated in some patients. Another method oftreatment in trying to reduce clotting and embolization leading to astroke includes left atrial appendage obliteration. Obliterationprocedures may occur during open cardiac surgery or, less invasively,during thoracoscopic procedure. However, it is recognized that numerouspatients with a high risk of stroke are not candidates for suchprocedures because of a compromised status in their health.

Due to the disadvantages and problems with the above noted treatmentprocedures, extensive developmental advancements have been attemptedwith left atrial appendage occlusion. This is a treatment strategy whichis directed to the prevention of blood clot formation within theinterior of the left atrial appendage. Known occlusion proceduresinclude the use of the “WATCHMAN device” manufactured by Atritech, Inc.,of Plymouth Minn., which is intended for use in patients withnon-valvular atrial fibrillation (AF), where heart surgery is a backup.Another device commonly termed “PLAATO” (Percutaneous Left AtrialAppendage Transcatether Occlusion) was generally recognized as the firstleft atrial appendage occlusion device. Both of the above noted LAAocclusion systems are introduced into the right atrium and are thenpassed into the left atrium through a patent formen ovale or through apuncture hole in the septum wall.

Known and/or recognized adverse events and limitations of the abovenoted procedures include pericardial effusion, incomplete LAA closure,dislodgment of the occluding device, blood clot formation on the deviceitself, requiring prolonged oral anticoagulation administration, as wellas the general risks associated with catheter based techniques, such asair embolism.

Accordingly, there is a need in the medical arts for an effectiveprocedure for overcoming the dangers associated with blood clotmigration within the interior of the left atrial appendage. Such aproposed and improved treatment procedure should be reliable, safe andovercome the disadvantages and problems associated with known treatmentsof the type set forth above.

SUMMARY OF THE INVENTION

The present invention is directed to an assembly and method forperforming an occlusion of the left atrial appendage in a safe andeffective manner which overcomes many of the disadvantages associatedwith known medical techniques for preventing blood clot migration fromthe interior of the left atrial appendage.

Accordingly, one or more preferred embodiments of the present inventioncomprise a delivery instrument including a distal end portion. Thedelivery instrument is structured to dispose the distal end portion inaligned and/or communicating relation with the left atrial appendageincluding the entrance thereof. In addition, occlusion materialcomprising at least one elongated, single strand of flexible material ismovably mounted on or connected to the delivery instrument andpositioned therewith through the heart into communicating relation withthe interior of the left atrial appendage.

In at least one preferred embodiment of the present invention theocclusion material comprises a single strand of elongated, flexiblematerial such as, but not limited to, nitinol wire. Its cooperativedisposition and structuring relative to the delivery instrument anddistal end portion facilitates a portion of the length of the one singlestrand of occlusion material to be movable along a portion of thedelivery instrument and preferably through an interior lumen thereof.Similarly, the length of the single strand is movable outwardly from andpreferably through the distal end portion into the interior of the leftatrial appendage. In more specific terms, at least a portion of thelength of the one single strand of occlusion material is movablydisposed on or within the delivery instrument and is progressivelymovable through the distal end as it is fed into the interior of theleft atrial appendage. Upon entry and due at least in part to theflexibility as well as the progressive feeding or passage thereof, theone single strand of occlusion material will form an “arbitrarilyintermingled array” of the occlusion material within the interior of theleft atrial appendage, as an additional amount or length of the singlestrand enters the appendage interior.

It is emphasized that the terminology used herein, specificallyincluding “arbitrarily intermingled array”, when referring to theocclusion material within the appendage interior, may be accuratelydescribed as various portions of the length of the single strand beingfolded, looped, curled, etc., about itself as the interior of theappendage progressively begins to fill. Accordingly, the location and/orposition of the various portions of the length within the appendageinterior, relative to each other and to the interior surfaces orportions of the appendage, will always be inconsistently disposed andtherefore “arbitrarily intermingled” or intermixed with one another,such as when applied to different left atrial appendages of differentpatients. Further, the various portions of the length of the singlestrand, forming the arbitrary intermingled array, are not connected orattached to one another or to the interior tissue portions of the leftatrial appendage.

Therefore, the single strand of occlusion material will differ fromconventional occlusion devices known in the art. More specifically, thesingle strand of occlusion material will not be formed into aconsistently structured frame, network, pattern or like occludingdevice, having a substantially predetermined configuration, shape orsize, as the single strand is progressively fed into the interior of theleft atrial appendage. In contrast, the at least one single strand ofocclusion material, due at least in part to its flexibility as well asits progressive entry into the appendage interior, will form differentlyshaped and dimensioned “arrays” of occlusion material comprisingintermixed, folded, overlapping, curled, etc. segments of the length ofthe single strand each time it is applied to the left atrial appendageof a different patient. As should be apparent, the “arbitrarilyintermixed array” of occlusion material may also be of differentdimensions and configurations dependent at least in part on the size ofthe left atrial appendage to which it is applied.

Moreover, in at least one preferred embodiment, one end of the onesingle strand of occlusion material may be fixedly connected to thedistal end portion and movable therewith into aligned, communicatingrelation with the interior of the left atrial appendage. This willprevent an inadvertent puncture or penetration of a loose or free end ofthe single strand into the wall tissue of the corresponding left atrialappendage being treated. As a result and as emphasized in greater detailherein, each progressively formed array disposed within the interiors ofthe left atrial appendage of different patients will be effectively“arbitrary” in size, dimension, disposition, etc.

Additional features of the delivery instrument, specifically includingthe distal end portion is its structural and operative features whichenable it to be used as a closure structure. Therefore, when alignedand/or disposed in communication with the interior of the appendage, thedistal end portion may be disposed in covering, closing relation to theentrance to the left arterial appendage in a secure manner. As a result,the progressively formed arbitrarily intermingled array of occlusionmaterial, as well as any blood clot interacting therewith, will beprevented from exiting the left atrial appendage but will remaintherein. Further, the distal end and/or closure structure may beselectively disposed into a closing orientation. The closing orientationmay be more specifically defined by a radially outward expansion thereofinto an increased dimension and configuration which facilitates theclosing and/or covering of the appendage entrance. When so disposed, thedistal end portion and/or closure structure defined thereby may bedisconnected from a remainder of the delivery instrument. Thereafter,the remainder of the delivery instrument may be subsequently removedafter single strand of occlusion material has been delivered and theocclusion of the left atrial appendage has been accomplished.

Other structural features which may be directly associated with themovable distal end portion and/or cover structure is the provision ofthe outer face or surface portion formed of a liquid impermeablematerial such as, but not limited to Dacron® as such, blood and bloodflow is prevented from passing through the distal end portion/closurestructure once it is disposed and expanded into its closing orientationand further disposed in closing relation to the appendage entrance.

Utilizing the assembly of the present invention as set forth above theintended method for accomplishing left atrial appendage occlusionincludes positioning the delivery instrument in communicating relationwith the interior of the left atrial appendage and expanding theremovable distal end portion or cover structure associated therewithinto a closing orientation. The closing orientation of the coverstructure is sufficient to close and/or cover the entrance, wherein aninner extremity of the distal end portion or cover structure is disposedat least partially within the interior of the left atrial appendage. Thecover structure is then connected or secured to the appendage entranceand at least one single strand of occlusion material is progressivelyfed into the interior of the left atrial appendage. In doing so, thearbitrarily intermingled array of occlusion material is progressivelyformed until a sufficient quantity or length of the one single strand isdisposed within the interior of the appendage and is of sufficient sizeand shape to correspond to the interior dimension and configuration ofthe left atrial appendage. As a result, any pooling of blood within theinterior of the appendage will interact with the arbitrarilyintermingled array of occlusion material, such that any clotting ofblood will be directly associated with the occlusion material itself.

These and other objects, features and advantages of the presentinvention will become clearer when the drawings as well as the detaileddescription are taken into consideration.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention,reference should be had to the following detailed description taken inconnection with the accompanying drawings in which:

FIG. 1 is a perspective view in partial cutaway of one preferredembodiment of a delivery instrument of the present invention structuredfor performing the occlusion of the left atrial appendage of the humanheart.

FIG. 2 is a perspective view in partial cutaway of another embodiment ofthe delivery instrument similar in operation to the embodiment of FIG.1.

FIG. 3 is a perspective view in partial cutaway of the deliveryinstrument in a contracted orientation which facilitates entry into theheart and access to the left atrial appendage.

FIG. 4 is a perspective view in partial cutaway and interior section ofthe embodiment of FIG. 3.

FIG. 5 is a perspective view in partial cutaway and interior section ofthe embodiment of FIGS. 3 and 4 representing the distal end portion ofthe delivery instrument in an expanded orientation.

FIG. 6 is a perspective view of the distal end portion of the embodimentof FIGS. 1, 2, and 5 wherein the distal end portion is disconnected fromthe remainder of the delivery instrument and is disposed in the expandedorientation.

FIGS. 7A and 7B are sequential steps in the attendant method of thepresent invention, wherein at least one single strand of occlusionmaterial is progressively delivered into the interior of the left atrialappendage and the formation thereof into an arbitrarily intermingledarray which accomplishes the intended occlusion.

FIGS. 8A-8C are perspective schematic views in partial cutawayrepresenting successive positioning of another embodiment of a coverstructure of the present invention in closing relation to the interiorof the left atrial appendage.

FIG. 9 is a perspective view of yet another preferred embodiment of thepresent invention.

FIG. 10 is a longitudinal sectional view of the embodiment of FIG. 9when in a cover structure thereof is in a collapsed orientation.

FIG. 10A is a detailed view of a gripping member portion of FIG. 10.

FIG. 11 is a longitudinal sectional view of the embodiment of FIGS. 9and 10 wherein the cover structure is in an expanded orientation.

FIG. 12 is a transverse sectional view and partial cutaway of the coverstructure of the embodiments of FIGS. 9 through 11 in an expandedorientation wherein occlusion material associated therewith is dispensedtherefrom.

FIG. 13 is a perspective view of the cover structure of the presentinvention in a covering relation to the entrance of the left atrialappendage wherein cover structure is in conformance with the peripheralconfiguration of the entrance.

FIG. 14 is an end view of the cover structure of the embodiments ofFIGS. 9 through 13 in an expanded orientation.

FIG. 15 is a top plan view of the embodiment of FIG. 14.

FIG. 16 is a detailed view in partial cutaway of the distal end of oneof a plurality of ribs associated with the cover structure of theembodiment of FIGS. 1 through 15, when the cover structure is in acollapsed orientation.

FIG. 17 is a sectional view in partial cutaway of one distal end of oneof a plurality of ribs and an included gripping member connected theretowhen the cover structure is in an expanded orientation.

Like reference numerals refer to like parts throughout the several viewsof the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention is directed to an instrument assembly andattendant method for accomplishing the occlusion of a left atrialappendage as schematically and collectively represented in theaccompanying Figures.

More specifically with primary reference to FIGS. 1 and 2, one or morepreferred embodiments of the present invention include a deliveryinstrument generally indicated as 10, which may include an elongatedcatheter, or delivery tube 12. The delivery catheter 12 includes aninterior lumen or channel as schematically represented in FIGS. 4 and 5and described in greater detail herein. The delivery instrument 10 alsoincludes a distal end portion generally indicated as 14 movable with thedelivery catheter 12 and selectively removable therefrom. As such, thedistal end portion 14 is positioned in aligned and communicatingrelation with the entrance 100 and the interior 102 of the left atrialappendage, generally and schematically represented as 104 in FIGS. 7Aand 7B. The distal end portion 14 may also define a cover structure forclosing and/or covering the entrance 100 of the interior 102 of the leftatrial appendage 104, when properly disposed into an expandedorientation or closing orientation, as represented in FIGS. 1, 2, 5, 6,7 a and 7B.

Therefore, when in the expanded orientation, the distal end portion orcover structure 14 facilitates the delivery of the single strand 20 ofocclusion material, generally indicated as 106, into the interior 102 ofthe appendage 104, from the delivery instrument 10. As represented, theocclusion material comprises at least one single strand 20 or aplurality of single strands (not shown). In either application, the atleast one single strand 20 is movably mounted on and connected to thedelivery instrument 10, and is disposable outwardly from the deliveryinstrument 10. More specifically the at least one single strand 20 isdisposable outwardly from the distal end portion or cover structure 14,such as through the distal extremity 22 thereof, into the interior 102of the left atrial appendage 104. Moreover in the various preferredembodiments of the present invention, the at least one single strand 20of occlusion material may have at least a portion of its lengthinitially stored and movable within the interior of the deliverycatheter or tube 12. A supply of such occlusion material may be mountedon and/or otherwise operatively associated with the delivery instrument10. Accordingly, the at least one single strand is “progressively” fedor delivered outwardly from the delivery instrument 10 preferablythrough the interior thereof and through the interior of the distal endportion 14, into the interior 102 of the left atrial appendage 104.

Additional structural features of the delivery instrument 10,specifically includes the distal end portion or cover structure 14,being removably attached to a corresponding end of the delivery catheter12, such as by a removable hub as at 24. It is emphasized that thedelivery instrument 10, as well as the distal end portion or coverstructure 14, may assume a variety of different structural and operativefeatures which facilitate the delivery of the occlusion material 106, inthe form of the at least one single strand of flexible material 20,progressively into the interior 102 of the left atrial appendage 104. Asshown in FIGS. 4 and 5, a threaded linkage assembly, generally indicatedas 26, is directly associated with the distal end portion 14. As such,the threaded linkage 26 is operatively structured to interact withinterior portions of the delivery tube or catheter 12, such as at member24′. As such, rotation of the interior rod 12′ will serve to rotate thethreaded linkage 26 through interaction with the thread member 24′. Thisin turn will cause an outward, radial expansion of the distal endportion 14 into what may be referred to as the aforementioned expandedorientation or closing orientation as it is disposed in covering orclosing relation to the entrance 100 of the interior 102 of the leftatrial appendage 104.

Therefore, the associated hub 24 may include internal threads or otherfeatures which, when rotated, will force a longitudinal movement of thehub 24 along the threaded linkage 26 as schematically represented bydirectional arrow 27. Such longitudinal movement of the connecting hub24 towards the distal extremity 22 of the distal end portion 14 willcause an outward, radial expansion of a plurality of flexible materialribs 30, which collectively define the side wall portions of the distalend portion 14. The flexibility of the ribs 30 is demonstrated by thedifferent positions or orientations thereof such as when the distal endportion 14 is connected to the corresponding end of the delivery tube orcatheter 12 in its compacted orientation prior to expansion. Inaddition, the end or extremity 26′ of the threaded linkage 26 may alsobe structured to facilitate the detachment or disconnection of thedistal end portion 14 from the remainder of the delivery instrument 10and/or delivery catheter 12 through appropriate manipulation of theremainder of the delivery instrument 10 as should be apparent.

It is of further note that the structure of the distal end portion orcover structure 14 may vary significantly in facilitating the selectivepositioning into its expanded orientation or closing orientation inorder to facilitate it covering or closing the entrance 100 of the leftatrial appendage 104. It is to be further noted that the size and/orconfiguration of the distal end portion and/or cover structure 14 mayvary at least partially based on the degree of outward or radialexpansion. The variances in circumferential and/or diametrical dimensionfacilitate the proper sizing and positioning of the distal end portionor cover structure 14 into covering or closing relation to the entrance100, as schematically represented in FIGS. 7A and 7B. As alsorepresented throughout the Figures, the delivery instrument 10,specifically including both the delivery catheter 12 and the distal endportion 14, may be further structured to accommodate the passage of thesingle strand 20 of occlusion material through the interior of thedelivery tube or catheter 12 and through the interior of the distal endportion 14 out of the distal extremity 22 of the distal end portion 14.

With primary reference to FIGS. 1 and 2, the distal end portion or coverstructure 14 may include an outer face 40 which is formed from a liquidimpermeable material such as, but not limited to, Dacron™. As such, theouter face 40 serves to restrict the flow of fluid between the leftatrium and the interior 102 of the left atrial appendage 104. Similarly,the exterior face 40, as well as the structure of the plurality of sideribs 30, serve to restrict the migration of any blood or blood clot fromthe interior 102 of the left atrial appendage 104, especially due to thefact that a pooling of blood or resultant blood clot will intermix orinteract with the occlusion material 106. As used herein, the termexterior face 40 is descriptive of the location of the liquidimpermeable face 40 within the interior of the atrium but substantiallyor entirely excluded from the interior 102 of the left atrial appendage104.

Further with regard to FIG. 1, the distal end portion or cover structure14 may also include one or more gripping members 42 preferably, but notexclusively, disposed about the outer periphery of the distal endportion 14 and/or exterior face 40. The disposition and structure of thegripping members 42 is such as to facilitate a secure, fixed attachmentsuch as by, but not limited to, penetration of the distal end portionand/or cover structure 14 in its closing or covering relation to theentrance 100 of the left atrial appendage 104. Gripping engagementand/or interaction of the gripping member 42 are also schematicallyrepresented in FIGS. 7A and 7B.

Yet another embodiment of the present invention includes a structuraland operative variation of the cover structure and is generallyrepresented as 114 in FIG. 8A-8C. More specifically, the cover structure114 comprises a plurality of ribs 130 structured and initially disposedto move with and relative to the delivery tube or catheter 12. Moreover,the ribs 130 may be extended out of the distal end of the delivery tube12 and through an outer sheath or like structure 13 into a radiallyexpanded position and closing orientation relative to the entrance 100to the interior 104 of the left atrial appendage 102, as represented inFIGS. 8A and 8B. Although not shown in FIGS. 8A-8C, Dacron or otherappropriate material 40 may be used on or at least partially define theouter face of the cover structure 114, as described with references tothe embodiment of FIG. 1.

Moreover, each or at least some of the ribs 130 include a pointed orother appropriately configured outer end 142 which engages and connects,such as by penetration, to the tissue substantially comprising the outerperiphery of the entrance 100 of the left atrial appendage 102. Suchpositioning of the outer ends 142 will maintain the cover structure 114in the expanded orientation and closing relation to the entrance 100 ofthe interior 102 as represented in FIGS. 8B and 8C. Once so positionedand after the single strand 20 of occlusion material 106 has beenprogressively passed into the interior 102 in the form of thearbitrarily intermingled array 110, the remainder of the deliveryinstrument 10′ and catheter 12 are detached from the cover structure 114and removed from the site.

With primary reference to FIGS. 7A and 7B, the occlusion material in oneor more preferred embodiments of the present invention comprises the atleast one single strand 20 of elongated, flexible material. The materialfrom which the single strand 20 is formed may include, but not belimited to, a nitinol wire or chord. While the progressive feeding ofthe at least one single strand 20 into the interior 102 of the leftatrial appendage 104 is described with reference to and in terms of thestructure of the embodiment of FIGS. 1-6, the described procedure and/ormethod is substantially the when the embodiment of FIGS. 8A-8C are used.The cooperative disposition and structure of the at least one singlestrand relative to the delivery instrument 10, delivery tube or catheter12 and distal end portion 14 facilitates a portion of the length of theone single strand 20 being movable preferably through an interior of thedelivery instrument 10, as schematically represented in FIGS. 4 and 5.Similarly, the length of the single strand 20 is movable through andoutwardly from the distal end portion and/or cover structure 14 into theinterior 102 of the left atrial appendage 104. More specifically, atleast a portion of the length of the at least one single strand 20 ofocclusion material 106 is movably disposed on or within the deliveryinstrument and is progressively movable through the distal end or coverstructure 14, as it is fed into the interior 102 of the left atrialappendage 104.

Upon entry and due at least in part to the flexibility as well as theprogressive feeding or passage of the one single strand 20, it willprogressively form into an “arbitrarily intermingled array” 110 of theocclusion material 106 as clearly represented in FIG. 7B. As should beapparent, once the distal end portion and/or closure structure 14 is inthe covering or closing relation to the entrance 100, as in FIGS. 7A and7B, the delivery instrument 10 may be selectively manipulated so as toforce movement or passage of the one single strand 20 of occlusionmaterial into the interior 102. Further, as demonstrated in FIG. 7B asadditional amounts or lengths of the single strand 20 enters theappendage interior 102 the “arbitrarily intermingled array” 110 of theinteriorly collected occlusion material 106 will be progressivelyformed.

It is emphasized that the term “arbitrarily intermingled array” 110 whendescribing the occlusion material 106, may serve to accurately describethe various portions of the length of the single strand 20 being folded,looped, curled, intermingled, etc. about itself as the interior 102 ofthe appendage 104 begins to fill, as schematically and successivelyrepresented in FIGS. 7A and 7B. Therefore, the rotation and/or positionof the various portions of the length of the single strand 20 within theappendage interior 102 will be “inconsistently” arranged and therefore“arbitrarily intermingled” or intermixed with one another, when theocclusion material 106 is applied to different left atrial appendages104 of different patients. It is further emphasized that in one or morepreferred embodiments, the various portions of the length of the singlestrand 20 will form the arbitrary intermingled array 110 and will notnecessarily be connected or attached to one another and not connected orattached to the tissue portions within the left atrial appendage 104.Therefore and as indicated above, due at least in part to theflexibility as well as the progressive entry of the at least one singlestrand 20 into the appendage interior 102, the at least one singlestrand 20 will form differently shaped and dimensioned “arrays” 110 ofocclusion material 106, as the various portions of the length of the onesingle strand 20 are intermixed in folding, overlapping, curled, etc.relation to one another.

As schematically represented, the arbitrarily intermingled array 110 ofocclusion material 106 may have different dimensions and/orconfigurations depending at least in part on the size of the interior102 of the left atrial appendage 104 to which it is applied. In at leastone preferred embodiment of the present invention, the arbitrarilyintermingled array 110 is dimensioned and configured to fill at least amajority of the interior 102 of the appendage 104 and/or substantiallyfill the entirety thereof. When so filled, the arbitrarily intermingledarray 110 will substantially conform or correspond to the interiorconfiguration of the left atrial appendage 104, in the manner clearlyrepresented in FIG. 7B.

This partial filling or complete filling will thereby serve toaccomplish an intended interaction of any blood pooling within theinterior 102 of the appendage 104. Moreover, the blood will interactwith the arbitrarily intermingled array 110 of occlusion material 106 ina manner which will maintain at least minimal blood circulation andavoid revascularization.

Additional features of the formed arbitrarily intermingled array 110 ofocclusion material 106 is the attachment of the proximal end 20′ to thedistal extremity 22 of the distal end portion or cover structure 14.This connection will prevent inadvertent penetration or puncturing ofthe interior wall tissue of the left atrial appendage 104. Further, uponcompletion of the formation of the arbitrarily intermingled array 110 ofocclusion material 106 within the interior 102 of the left atrialappendage 104, the remainder of the delivery instrument 110, such as thedelivery tube or catheter 12 is detached from the corresponding end orhub 24 and/or the extremity 26′ of the linkage 26 and removed from theinterior of the heart. As such, the opposite or distal end 20″ of the atleast one single strand 20 of occlusion material 106 will remainattached to the distal end portion or cover structure 14.

Yet another preferred embodiment of the assembly for performing anocclusion of the left atrial appendage is represented in detail in FIGS.9 through 17. More specifically, a delivery instrument is generallyindicated as 200 and includes an introduction member 202 structured forintroduction or passage into the heart in an operative position. Theoperative position of the delivery instrument 200 comprises its directcommunicating relation with the left atrial appendage, such asschematically represented with regard to the description of thedifferent embodiments of FIGS. 7A, 7B and 8A-8C.

In addition, the delivery instrument 200 includes a positioning member204 initially disposed telescopically within the interior of theintroduction member 202 so as to be movable relative thereto. A coverstructure 206 is initially connected to the distal end of thepositioning member 204 so as to move therewith between an expandedorientation of FIGS. 11 through 15 and a collapsed orientation asrepresented in FIGS. 10 and 10A. As will be described in greater detailhereinafter, the cover structure 206 is removably connected to thepositioning member 204 so as to be detached therefrom when the coverstructure 206 is operatively disposed in closing relation to theentrance of the left atrial appendage 104, as schematically representedin FIG. 7B with regard to the above described embodiment and as alsorepresented at least schematically in FIG. 13.

The selective detachment of the cover structure 206 from the positioningmember 204 may be accomplished by an appropriate linkage or connector226 which may be structurally and/or operatively similar to theconnecting linkage 26 associated with the embodiments of FIGS. 1 through6. It is emphasized that other connecting linkage may be utilized tofacilitate the accurate position of the cover structure 206, when in thecollapsed orientation of FIGS. 10 and 10A, as well as the detachment ofthe delivery instrument 200 there from, when the cover structure 206 isoperatively disposed in the aforementioned covering relation to theentrance and interior of the left atrial appendage 104. As clearlyrepresented in FIGS. 12 through 15, the cover structure 206 includes aplurality of ribs 208 each formed of a material having sufficientflexibility to provide an “inherent bias” thereto, which facilitatestheir “automatic” disposition from the collapsed orientation of FIGS. 10and 10A into the expanded orientation of FIGS. 11 through 15.

Accordingly, the collapsed orientation of the cover structure 206comprises the plurality of ribs 208 being disposed in substantiallylongitudinal alignment with one another and with the length and/orcentral axis of the delivery instrument 200. However, upon dispositionof the cover structure 206 through the open end 202′ of the introductionmember 202 the inherent bias associated with each of the plurality ofribs will force them into the expanded orientation comprising a radiallyoutward, spaced apart orientation as represented throughout FIGS. 11through 15. Additional features of the cover structure 206 include acentral hub 210 interconnected to and disposed in interconnectingrelation with each of the plurality of flexible material ribs 208.Therefore, the aforementioned expanded orientation of the cover member206 may be further defined by the plurality of ribs 208 extendingradially outward from the hub 210 in spaced apart orientation as clearlyrepresented in FIG. 15.

Features of the cover structure 206 comprise the inclusion of theplurality of gripping members 212 connected to free or outer distal ends208′ of at least some of the plurality of ribs 208. With primaryreference to FIGS. 16 and 17, the gripping members 212 may have apointed or other appropriate configuration to facilitate the penetrationof the left atrial appendage 104 in an area adjacent to the entrancethereof as also schematically represented in the embodiments of FIGS. 8Athrough 8C. Further, each of the gripping members 212 is formed of amaterial having sufficient flexibility to also include theaforementioned “inherent bias”. Accordingly, when each of the pluralityof ribs 208 are in the collapsed orientation on the interior of theintroduction member 202, the plurality of gripping members 212 aresubstantially coplanar or at least longitudinally aligned with theremainder of the corresponding ones of the distal ends 208′ as clearlyrepresented in FIGS. 10A and 16. Moreover, corresponding ones of thedistal ends 208′ may have an at least partially apertured constructionas at 208″ wherein the gripping members 212 are disposed within theinterior of the corresponding opening or aperture, as at 208″ when thecover structure 206 is in the collapsed orientation.

However, due to the aforementioned inherent bias, once the ribs pass outthrough the opening 202′ into the expanded orientation of FIGS. 11through 15, the plurality of gripping members 212 will extendtransversely outward from the corresponding distal end 208′. Inaddition, each of the plurality of distal ends 208′, whether directlyassociated with a gripping member 212 or not, are structured to have anat least partially curvilinear configuration as clearly represented inFIG. 17. Therefore, the inherent bias integrated into each of theplurality of ribs 208, as well as the distal ends 208′ and the grippingmembers 212, will facilitate the “automatic” assumption of theconfiguration of the gripping members 212 and each of the distal ends208′ as represented in FIG. 17. As will be explained in greater detailhereinafter, each of the plurality of gripping members 212 extendtransversely outward from the outer side 213 of the cover structure 206,wherein the inner or interior side 215 of the cover structure 206 facesinwardly towards the interior of the left atrial appendage 104 when thecover structure 206 is disposed in the expanded orientation and incovering relation to the entrance to the left atrial appendage 104,similar to the schematic representation of FIGS. 7A and 7B.

Other structural features of the cover structure 206 include a facingmaterial or structure 218 disposed in covering relation to the pluralityof ribs when in either the expanded or the collapsed orientations, asdescribed above. Moreover, the facing material 218 includes the outerside 213 and the inner side 215 and may be formed of a Dacron® or otherflexible and liquid impermeable material. The flexibility of the facingmaterial 218 facilitates its movement in connected, covering relation tothe plurality of ribs 208 as they move and/or are positioned between thecollapsed and the expanded orientations.

Similar to the embodiment of FIGS. 1 through 7, and again with at leastpartial reference to the schematic representations of FIGS. 7A and 7B,the delivery instrument 200 is structured to dispense at least onesingle strand of occlusion material 220 into the interior 102 of theleft atrial appendage. The occlusion material 220 is progressivelydispensed or fed through the cover structure 206 and more specificallythrough the opening 210′ of the hub 210 into the interior 102 of theleft atrial appendage 104. Accordingly, the occlusion material 220comprises at least one single strand of elongated flexible material suchas, but not limited to, nitinol wire or chord. As applied, the length ofthe single strand of occlusion material 220 is progressively fed fromthe interior of the delivery instrument 200 and more specifically fromthe interior of the positioning members 204 through the hub 210.Moreover, a sufficient length of the occlusion material 220 iscontinuously and progressively fed into the interior 102 until at leasta majority and/or substantially the entirety of the interior 102 isfilled. Upon entry and due at least in part to the flexibility and thequantity of the single strand of occlusion material 220 as well as theprogressively feeding or passage thereof to the interior 102, the singlestrand of occlusion material 220 will progressively form into an“arbitrarily intermingled array”. Such introduction or dispensing of thesingle strand of occlusion material 220 is accomplished while the coverstructure 206 is in the aforementioned covering relation to the entranceof the interior 102 of the left atrial appendage 104.

Additional features of the cover structure 206 specifically, but notexclusively, including the cooperative structural and operative featuresof the plurality of ribs 208, gripping members 212, etc. include theplurality of ribs being collectively dimensioned and having sufficientflexibility to dispose the plurality of distal ends 208′ into connectedrelation with the tissue of the left atrial appendage immediatelyadjacent to the entrance thereof. Moreover, the distal ends 208′collectively are disposed to substantially conform to the peripheralconfiguration of the entrance as generally represented in FIG. 13.

It is recognized by medical personnel familiar with the intendedprocedure of occluding the left atrial appendage that the entrancethereof has a generally non-symmetrical peripheral configuration. Inaddition, medical personnel have also termed the peripheralconfiguration of the entrance of the left atrial appendage to be atleast partially or substantially oval. Accordingly, the flexibility anddimensions of the plurality of ribs allow them to substantially conformto the normal or conventional “oval” or other normal or conventionalconfiguration of the periphery of the entrance of the left atrialappendage when disposed in the covering relation thereto as describedabove.

Since many modifications, variations and changes in detail can be madeto the described preferred embodiment of the invention, it is intendedthat all matters in the foregoing description and shown in theaccompanying drawings be interpreted as illustrative and not in alimiting sense. Thus, the scope of the invention should be determined bythe appended claims and their legal equivalents.

Now that the invention has been described,

What is claimed is:
 1. An assembly structured to perform an occlusion ofthe left atrial appendage, said assembly comprising: a deliveryinstrument structured for operative disposition in communicatingrelation with an interior of the left atrial appendage, said deliveryinstrument including a cover structure removably connected thereto,occlusion material comprising at least one elongated strand of flexiblematerial mounted on said delivery instrument, said delivery instrumentoperative for progressive axial dispensing of the length of said atleast one strand therefrom into the interior of the left atrialappendage, when said delivery instrument is in said operativedisposition, a dispensed portion of said at least one strand being ofsufficient length and flexibility to at least partially fill and conformto the interior of the left atrial appendage, said dispensed portion ofsaid at least one strand being of sufficient length and flexibility todefine a progressively formed arbitrarily intermingled array of saidocclusion material within the interior of the left atrial appendage,said cover structure structurally adapted for disposition in a coveringorientation, wherein said covering orientation comprises said coverstructure disconnected from said delivery instrument and disposed incovering relation to an entrance to the left atrial appendage, saidcover structure comprising a plurality of ribs movable between acollapsed orientation and an expanded orientation, at least a majorityof said plurality of ribs including a gripping member movably connectedto a free distal end thereof, said collapsed orientation comprising saidgripping members disposed in substantially coplanar relation with aremainder of corresponding ones of said distal ends when within aninterior of said delivery instrument, said expanded orientation furthercomprises each of said gripping members biased transversely outward fromcorresponding ones of said distal ends, when said cover structure is insaid expanded orientation, wherein said at least one strand forming thearbitrarily intermingled array is not attached to itself along itslength and is not attached to tissue portions of the heart correspondingto the left atrial appendage when the cover structure is in saidcovering orientation, and wherein when in the covering orientation, eachof said plurality of ribs extend radially outwardly and do not projectdistally of a distal end of a distal end portion.
 2. An assembly asrecited in claim 1 wherein said expanded orientation comprises saidplurality of ribs extending radially outward from said cover structureinto connected relation with the left atrial appendage immediatelyadjacent a periphery of an entrance thereof.
 3. An assembly as recitedin claim 2 wherein said collapsed orientation comprises said pluralityof ribs disposed within an interior of said delivery instrument insubstantially longitudinally aligned relation to one another.
 4. Anassembly as recited in claim 1 wherein said collapsed orientationcomprises said plurality of ribs disposed within an interior of saiddelivery instrument in substantially aligned relation to a length ofsaid delivery instrument.
 5. An assembly as recited in claim 1 whereinsaid covering orientation further comprises said distal ends of saidplurality of ribs collectively disposed in conformance with a peripheralconfiguration of the entrance of the left atrial appendage.
 6. Anassembly as recited in claim 1 wherein said cover structure furthercomprises a facing structure connected to said plurality of ribs incovering relation thereto, said covering orientation further comprisingsaid facing structure structurally adapted to be disposed in coveringrelation to the entrance of the left atrial appendage.
 7. An assembly asrecited in claim 6 wherein said facing structure is formed of aflexible, liquid impermeable material movable with said plurality ofribs into and out of said collapsed and expanded orientations.
 8. Anassembly as recited in claim 1 wherein said gripping members aredisposed and configured to at least partially penetrate the left atrialappendage adjacent the entrance thereof.
 9. An assembly as recited inclaim 1 wherein said gripping members extend transversely outward froman outer side of corresponding ones of said distal ends of saidplurality of ribs.
 10. An assembly as recited in claim 9 wherein saiddistal ends comprise a curvilinear configuration extending inwardlytowards the interior of said left atrial appendage at least when saidcover structure is in said expanded orientation and in covering relationto the entrance of the interior of the left atrial appendage.
 11. Anassembly as recited in claim 1 wherein said delivery instrumentcomprises an introduction member and a positioning member disposedwithin said introduction member, said cover structure connected to saidpositioning member and movable therewith relative to said introductionmember between said collapsed and said expanded orientations.
 12. Anassembly as recited in claim 11 wherein said cover structure isremovably connected to said positioning member and detachable therefromat least when said cover structure is in said covering orientation. 13.An assembly as recited in claim 1 wherein said cover structure comprisesa hub, said plurality of ribs connected to and movable with and relativeto said hub between said collapsed and said expanded orientations; saidhub cooperatively structured and disposed relative to said at least onestrand to facilitate progressive passage of a length of said one strandthrough said hub, into the interior of the left atrial appendage whensaid delivery instrument is in said operative disposition and said coverstructure is in said covering orientation; said dispensed portion ofsaid at least one strand being of sufficient length and flexibility todefine a progressively formed, arbitrarily intermingled array of saidocclusion material within the interior of the left atrial appendage. 14.An assembly as recited in claim 1 wherein said covering orientationfurther comprises free distal ends of said plurality of ribscollectively connected to and disposed in conformance with a peripheralconfiguration of the entrance of the left atrial appendage.
 15. Anassembly as recited in claim 1 wherein said covering orientation furthercomprises at least a portion of said cover structure disposed exteriorlyof the entrance of the left atrial appendage.
 16. An assembly as recitedin claim 1 wherein said at least one strand includes a proximal end anda distal end each remaining connected to said cover structure concurrentto said cover structure disposed in said covering orientation anddisconnected from said delivery instrument.
 17. An assembly structuredto perform an occlusion of the left atrial appendage, said assemblycomprising: a delivery instrument structured for operative dispositionin communicating relation with an interior of the left atrial appendage,said delivery instrument including a cover structure removably connectedthereto, occlusion material comprising at least one elongated strand offlexible material mounted on said delivery instrument, said deliveryinstrument operative for progressive axial dispensing of the length ofsaid at least one strand therefrom into the interior of the left atrialappendage, when said delivery instrument is in said operativedisposition, a dispensed portion of said at least one strand being ofsufficient length and flexibility to define a progressively formedarbitrarily intermingled array of said occlusion material within theinterior of the left atrial appendage, said cover structure structurallyadapted to be disposed in a covering orientation, wherein said coveringorientation comprises said cover structure disconnected from saiddelivery instrument and disposed in covering relation to an entrance tothe left atrial appendage, said covering orientation comprising at leasta portion of said cover structure disposed exteriorly of the entrance ofthe left atrial appendage, said at least one strand including a proximalend and a distal end each remaining connected to said cover structureconcurrent to said cover structure being in said covering orientation,said cover structure comprising a plurality of ribs movable between acollapsed orientation and an expanded orientation, at least a majorityof said plurality of ribs including a gripping member movably connectedto a free distal end thereof, said collapsed orientation comprising saidgripping members disposed in substantially coplanar relation with aremainder of corresponding ones of said distal ends on an interior ofsaid delivery instrument, said expanded orientation further comprisingeach of said gripping members biased transversely outward fromcorresponding ones of said distal ends, when said cover structure is insaid expanded orientation, and wherein said at least one strand formingthe arbitrarily intermingled array is not attached to itself along itslength and is not attached to tissue portions of the heart correspondingto the left atrial appendage when the cover structure is in saidcovering orientation, and wherein when in the covering orientation, eachof said plurality of ribs extend radially outwardly and do not projectdistally of a distal end of a distal end portion.
 18. An assemblystructured to perform an occlusion of the left atrial appendage, saidassembly comprising: a delivery instrument structured for operativedisposition in communicating relation with an interior of the leftatrial appendage, said delivery instrument including a cover structureremovably connected thereto, occlusion material comprising at least oneelongated strand of flexible material mounted on said deliveryinstrument, said delivery instrument operative for progressive axialdispensing of the length of said at least one strand therefrom into theinterior of the left atrial appendage, when said delivery instrument isin said operative disposition, a dispensed portion of said at least onestrand being of sufficient length and flexibility to at least partiallyfill and conform to the interior of the left atrial appendage, saiddispensed portion of said at least one strand being of sufficient lengthand flexibility to define a progressively formed arbitrarilyintermingled array of said occlusion material within the interior of theleft atrial appendage, said cover structure structurally adapted fordisposition in a covering orientation, wherein said covering orientationcomprises said cover structure disconnected from said deliveryinstrument and disposed in covering relation to an entrance to the leftatrial appendage, said cover structure comprising a plurality of ribsmovable between a collapsed orientation and an expanded orientation, atleast a majority of said plurality of ribs including a gripping membermovably connected to a free distal end thereof, said collapsedorientation comprising said gripping members disposed in substantiallycoplanar relation with a remainder of corresponding ones of said distalends when within an interior of said delivery instrument, said expandedorientation further comprises each of said gripping members biasedtransversely outward from corresponding ones of said distal ends, whensaid cover structure is in said expanded orientation, wherein said atleast one strand forming the arbitrarily intermingled array is notattached to itself along its length and is not attached to tissueportions of the heart corresponding to the left atrial appendage whenthe cover structure is in said covering orientation, and wherein when inthe covering orientation, each of said plurality of ribs extend radiallyoutwardly and do not project distally of a distal end of a distal endportion.
 19. An assembly structured to perform an occlusion of the leftatrial appendage, said assembly comprising: a delivery instrumentstructured for operative disposition in communicating relation with aninterior of the left atrial appendage, said delivery instrumentincluding a cover structure removably connected thereto, occlusionmaterial comprising at least one elongated strand of flexible materialmounted on said delivery instrument, said delivery instrument operativefor progressive axial dispensing of the length of said at least onestrand therefrom into the interior of the left atrial appendage, whensaid delivery instrument is in said operative disposition, a dispensedportion of said at least one strand being of sufficient length andflexibility to define a progressively formed arbitrarily intermingledarray of said occlusion material within the interior of the left atrialappendage, said cover structure being structurally adapted to bedisposed in a covering orientation, wherein said covering orientationcomprises said cover structure disconnected from said deliveryinstrument and disposed in covering relation to an entrance to the leftatrial appendage, said covering orientation comprising at least aportion of said cover structure disposed exteriorly of the entrance ofthe left atrial appendage, said at least one strand including a proximalend and a distal end each remaining connected to said cover structureconcurrent to said cover structure being in said covering orientation,said cover structure comprising a plurality of ribs movable between acollapsed orientation and an expanded orientation, at least a majorityof said plurality of ribs including a gripping member movably connectedto a free distal end thereof, said collapsed orientation comprising saidgripping members disposed in substantially coplanar relation with aremainder of corresponding ones of said distal ends on an interior ofsaid delivery instrument, and said expanded orientation furthercomprising each of said gripping members biased transversely outwardfrom corresponding ones of said distal ends, when said cover structureis in said expanded orientation, wherein said at least one strandforming the arbitrarily intermingled array is not attached to itselfalong its length and is not attached to tissue portions of the heartcorresponding to the left atrial appendage when the cover structure isin said covering orientation, and wherein when in the coveringorientation, each of said plurality of ribs extend radially outwardlyand do not project distally of a distal end of a distal end portion.